Full-Time Senior Project Manager

RQM+ is a leading MedTech service provider with a global team of regulatory and quality experts. We provide clinical trial, lab, and reimbursement services, reducing risk and supporting market access for medical devices, digital therapeutics, and diagnostics. We have deep expertise in all clinical specialties.

Senior Project Manager responsibilities include successful planning, implementation, and execution of contracted activities.

Responsibilities:

• Manages all activities related to clinical studies.
• Manages full scope regional and global projects.
• Leads project teams.
• Builds and maintains positive client relationships.
• Negotiates with clients to maintain RQM+ processes.
• Reviews and identifies project trends, proactively responding to client needs.
• Develops early warning systems for potential obstacles.
• Identifies, defines, and documents training requirements.
• Manages change management.
• Ensures projects adhere to SOPs and Work Plans.
• Ensures project timelines are met.
• Identifies and documents process updates.
• Maintains client relationships and project reporting.
• Assists with developing and updating internal processes.
• Provides project support to Managers.
• Oversees delegation of support staff.
• Assists in capability and proposal presentations.
• Supports contracts and proposal execution.
• Represents senior management in contract negotiations.
• Provides performance feedback to team members.
• Maintains knowledge of FDA regulations, GCP, and ICH Guidelines.
• Maintains personal currency documentation.

Requirements:

• Nursing or related University degree (US Bachelor level or equivalent).
• 5+ years direct clinical trial experience in a CRO.
• 2+ years management experience.
• Global project management experience in MedTech, with CRO experience preferred.
• Experience managing people in a scientific/clinical environment.
• Clinical Monitoring and/or Data Management experience.
• Financial management skills.
• Up to 20% travel, including international.
• Knowledge of clinical research process (pre-clinical to post-approval).
• Strong communication skills (verbal and written).
• Strong organizational and interpersonal skills.
• Ability to manage multiple priorities.
• Problem-solving and financial negotiation skills.
• Knowledge of current ICH GCP guidelines.
• Proficiency in Word, Excel, and PowerPoint.

Behaviors:

• Action-Oriented
• Approachability
• Building Effective Teams
• Business Acumen
• Career Ambition
• Composure
• Courage (Managerial)
• Customer Focus
• Decision Quality
• Informing
• Integrity & Trust
• Interpersonal Savvy
• Planning

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